Cleared Traditional

K770393 - PROPANE, HIGH PURITY, INSTRUMENT GRADE
(FDA 510(k) Clearance)

K770393 · Hycel, Inc. · Chemistry
Apr 1977
Decision
57d
Days
Class 1
Risk

K770393 is an FDA 510(k) clearance for the PROPANE, HIGH PURITY, INSTRUMENT GRADE, a Flame Emission Photometer For Clinical Use (Class I — General Controls, product code JJO), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1977, 57 days after receiving the submission on February 28, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2540.

Submission Details

510(k) Number K770393 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 1977
Decision Date April 26, 1977
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJO — Flame Emission Photometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2540